Idebenone for the Preventive Treatment of Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
Idebenone improves energy metabolism similarly to Coenzyme Q10, which is effective in migraine prophylaxis. The investigators compare idebenone (90 mg/day, 270 mg/day) and placebo in 180 migraine patients in a double-blind, randomized, placebo-controlled, multicenter trial to study whether Idebenone is superior to placebo in the prevention of episodic migraine with or without aura.
Eligibility criteria
Qualifiers
Clinical diagnosis of episodic migraine.
Patients (18-65 years) were eligible if they met International Headache Society (IHS) criteria for episodic migraine with/ without aura with a migraine history 1 year
Two to eight attacks per month, 5 days/month of interval headaches.
No over consumption of acute anti-migraine medication.
Disqualifiers
Clinical diagnosis of chronic migraine.
Subjects previously discontinued idebenone due to adverse events.
Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
Subjects with continuous headaches.
Trial design
Treatments tested in this trial
- Placebo
- 90mg Idebenone
- 270mg Idebenone
Treatment groups
180 Participants
are divided into 3 treatment groupsLocations
1Kaiming Liu370001, HangzhouZhejiang, China
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Source ClinicalTrials.gov